(RTTNews) - Celularity Inc. (CELU) CEO and Chairman Robert Hariri said that its Biovance and Biovance 3L products will continute to be eligible for medicare coverage under the recent withdrawal of skin substitute Local Coverage Determinations or LCDs by Centers for Medicare & Medicaid Services' or CMS.
CEO welcomed the action taken by CMS Administrator Mehmet Oz, that will be effective on January 1, 2026.
CMS has revealed its plan to withdraw LSDs for skin substitute grafts/Cellular and Tissue-based products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers on December 24.
Under the Medicare 2026 Skin Substitute Update, CMS established LCDs to define which products qualify for Medicare reimbursement. While these rules initially rescinded coverage for 158 competing products, the LCDs were subsequently withdrawn on December 24, 2025, while maintaining a new flat-rate payment structure.
However, despite CMS withdrawing the LCDs effective January 1, 2026, Medicare will pay a flat rate of $127.28 per square centimetre, which will remain unchanged for all skin substitute applications in doctor offices and hospital outpatient settings.
Hariri further said that Biovance can operate sustainably under this payment model. He also highlighted Celularity's GMP/GTP-certified manufacturing facility in New Jersey, which produces both commercial biomaterials and investigational cell therapies, and noted the company's use of advanced, digitised, and AI-enabled Industry 5.0 manufacturing systems to support efficiency and supply chain resilience.
"Consistent with our emphasis on real-world evidence gained from actual clinical use of our products, we have integrated an 'Industry 5.0' approach into our manufacturing operations, introducing digitisation and AI and building adaptable and robust value chains and production systems," Dr Hariri added.
Over the year, CELU traded in the range of $1.00 and $4.35.On Friday, CELU closed trading 1.52% higher at $1.34.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
